Gxp Functional Test Lead
Capgemini
Gxp Functional Test Lead
Job Description
Gxp Functional Test Lead
📋 Job Overview
Capgemini is seeking an experienced GxP Functional Test Lead to manage and execute testing activities for applications and systems under GxP compliance standards. The role requires strong knowledge of GxP regulations, validation processes, and hands-on functional testing experience in regulated environments like pharmaceuticals, life sciences, or healthcare. The ideal candidate will lead teams, ensure compliance with regulatory frameworks, and deliver high-quality testing in validated settings.
📍 Location: Chennai (ex Madras)
💼 Experience Level: Experienced Professionals
🏢 Business Unit: Other Delivery units
🎯 Key Responsibilities
- Manage and execute testing activities for GxP-compliant applications and systems
- Lead testing teams and manage deliverables in validated environments
- Ensure compliance with GxP regulations and validation processes
- Prepare and review test documentation including plans, protocols, and reports
- Support audits and stakeholder management in regulated settings
✅ Required Qualifications
- Strong understanding of GxP compliance and CSV principles
- Hands-on experience in functional testing for regulated environments
- Expertise in test documentation (Test Plans, Protocols, Reports) per GxP standards
- Familiarity with FDA 21 CFR Part 11, Annex 11, and other regulatory frameworks
- Proficiency in test management tools (e.g., HP ALM, JIRA)
- Ability to lead teams and manage testing deliverables in a validated environment
⭐ Preferred Qualifications
- Exposure to automation testing in GxP environments (e.g., using tools like Tricentis Tosca, Selenium)
- Knowledge of Agile methodologies and hybrid delivery models
- Experience with data integrity principles and electronic records/e-signatures compliance
- Familiarity with SAP, LIMS, or other enterprise systems in life sciences
🛠️ Required Skills
- GxP compliance
- CSV principles
- Functional testing
- Test documentation (Test Plans, Protocols, Reports)
- FDA 21 CFR Part 11
- Annex 11
- Regulatory frameworks
- HP ALM
- JIRA
- Team leadership
- Automation testing
- Tricentis Tosca
- Selenium
- Agile methodologies
- Hybrid delivery models
- Data integrity principles
- Electronic records/e-signatures compliance
- SAP
- LIMS
- Enterprise systems in life sciences
- Communication
- Stakeholder management
- Audit support
🎁 Benefits & Perks
- Range of career paths and internal opportunities within Capgemini group
- Personalized career guidance from leaders
- Comprehensive wellness benefits including health checks, telemedicine, and insurance with top-ups
- Elder care, partner coverage, and new parent support via flexible work
- Opportunities to work on cutting-edge projects in tech and engineering with industry leaders
- Solutions to overcome societal and environmental challenges
Locations
- Chennai (ex Madras), India
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,200,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- GxP complianceintermediate
- CSV principlesintermediate
- Functional testingintermediate
- Test documentation (Test Plans, Protocols, Reports)intermediate
- FDA 21 CFR Part 11intermediate
- Annex 11intermediate
- Regulatory frameworksintermediate
- HP ALMintermediate
- JIRAintermediate
- Team leadershipintermediate
- Automation testingintermediate
- Tricentis Toscaintermediate
- Seleniumintermediate
- Agile methodologiesintermediate
- Hybrid delivery modelsintermediate
- Data integrity principlesintermediate
- Electronic records/e-signatures complianceintermediate
- SAPintermediate
- LIMSintermediate
- Enterprise systems in life sciencesintermediate
- Communicationintermediate
- Stakeholder managementintermediate
- Audit supportintermediate
Required Qualifications
- Strong understanding of GxP compliance and CSV principles (experience)
- Hands-on experience in functional testing for regulated environments (experience)
- Expertise in test documentation (Test Plans, Protocols, Reports) per GxP standards (experience)
- Familiarity with FDA 21 CFR Part 11, Annex 11, and other regulatory frameworks (experience)
- Proficiency in test management tools (e.g., HP ALM, JIRA) (experience)
- Ability to lead teams and manage testing deliverables in a validated environment (experience)
Preferred Qualifications
- Exposure to automation testing in GxP environments (e.g., using tools like Tricentis Tosca, Selenium) (experience)
- Knowledge of Agile methodologies and hybrid delivery models (experience)
- Experience with data integrity principles and electronic records/e-signatures compliance (experience)
- Familiarity with SAP, LIMS, or other enterprise systems in life sciences (experience)
Responsibilities
- Manage and execute testing activities for GxP-compliant applications and systems
- Lead testing teams and manage deliverables in validated environments
- Ensure compliance with GxP regulations and validation processes
- Prepare and review test documentation including plans, protocols, and reports
- Support audits and stakeholder management in regulated settings
Benefits
- general: Range of career paths and internal opportunities within Capgemini group
- general: Personalized career guidance from leaders
- general: Comprehensive wellness benefits including health checks, telemedicine, and insurance with top-ups
- general: Elder care, partner coverage, and new parent support via flexible work
- general: Opportunities to work on cutting-edge projects in tech and engineering with industry leaders
- general: Solutions to overcome societal and environmental challenges
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Answer 10 quick questions to check your fit for Gxp Functional Test Lead @ Capgemini.
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Gxp Functional Test Lead
Capgemini
Gxp Functional Test Lead
Job Description
Gxp Functional Test Lead
📋 Job Overview
Capgemini is seeking an experienced GxP Functional Test Lead to manage and execute testing activities for applications and systems under GxP compliance standards. The role requires strong knowledge of GxP regulations, validation processes, and hands-on functional testing experience in regulated environments like pharmaceuticals, life sciences, or healthcare. The ideal candidate will lead teams, ensure compliance with regulatory frameworks, and deliver high-quality testing in validated settings.
📍 Location: Chennai (ex Madras)
💼 Experience Level: Experienced Professionals
🏢 Business Unit: Other Delivery units
🎯 Key Responsibilities
- Manage and execute testing activities for GxP-compliant applications and systems
- Lead testing teams and manage deliverables in validated environments
- Ensure compliance with GxP regulations and validation processes
- Prepare and review test documentation including plans, protocols, and reports
- Support audits and stakeholder management in regulated settings
✅ Required Qualifications
- Strong understanding of GxP compliance and CSV principles
- Hands-on experience in functional testing for regulated environments
- Expertise in test documentation (Test Plans, Protocols, Reports) per GxP standards
- Familiarity with FDA 21 CFR Part 11, Annex 11, and other regulatory frameworks
- Proficiency in test management tools (e.g., HP ALM, JIRA)
- Ability to lead teams and manage testing deliverables in a validated environment
⭐ Preferred Qualifications
- Exposure to automation testing in GxP environments (e.g., using tools like Tricentis Tosca, Selenium)
- Knowledge of Agile methodologies and hybrid delivery models
- Experience with data integrity principles and electronic records/e-signatures compliance
- Familiarity with SAP, LIMS, or other enterprise systems in life sciences
🛠️ Required Skills
- GxP compliance
- CSV principles
- Functional testing
- Test documentation (Test Plans, Protocols, Reports)
- FDA 21 CFR Part 11
- Annex 11
- Regulatory frameworks
- HP ALM
- JIRA
- Team leadership
- Automation testing
- Tricentis Tosca
- Selenium
- Agile methodologies
- Hybrid delivery models
- Data integrity principles
- Electronic records/e-signatures compliance
- SAP
- LIMS
- Enterprise systems in life sciences
- Communication
- Stakeholder management
- Audit support
🎁 Benefits & Perks
- Range of career paths and internal opportunities within Capgemini group
- Personalized career guidance from leaders
- Comprehensive wellness benefits including health checks, telemedicine, and insurance with top-ups
- Elder care, partner coverage, and new parent support via flexible work
- Opportunities to work on cutting-edge projects in tech and engineering with industry leaders
- Solutions to overcome societal and environmental challenges
Locations
- Chennai (ex Madras), India
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,200,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- GxP complianceintermediate
- CSV principlesintermediate
- Functional testingintermediate
- Test documentation (Test Plans, Protocols, Reports)intermediate
- FDA 21 CFR Part 11intermediate
- Annex 11intermediate
- Regulatory frameworksintermediate
- HP ALMintermediate
- JIRAintermediate
- Team leadershipintermediate
- Automation testingintermediate
- Tricentis Toscaintermediate
- Seleniumintermediate
- Agile methodologiesintermediate
- Hybrid delivery modelsintermediate
- Data integrity principlesintermediate
- Electronic records/e-signatures complianceintermediate
- SAPintermediate
- LIMSintermediate
- Enterprise systems in life sciencesintermediate
- Communicationintermediate
- Stakeholder managementintermediate
- Audit supportintermediate
Required Qualifications
- Strong understanding of GxP compliance and CSV principles (experience)
- Hands-on experience in functional testing for regulated environments (experience)
- Expertise in test documentation (Test Plans, Protocols, Reports) per GxP standards (experience)
- Familiarity with FDA 21 CFR Part 11, Annex 11, and other regulatory frameworks (experience)
- Proficiency in test management tools (e.g., HP ALM, JIRA) (experience)
- Ability to lead teams and manage testing deliverables in a validated environment (experience)
Preferred Qualifications
- Exposure to automation testing in GxP environments (e.g., using tools like Tricentis Tosca, Selenium) (experience)
- Knowledge of Agile methodologies and hybrid delivery models (experience)
- Experience with data integrity principles and electronic records/e-signatures compliance (experience)
- Familiarity with SAP, LIMS, or other enterprise systems in life sciences (experience)
Responsibilities
- Manage and execute testing activities for GxP-compliant applications and systems
- Lead testing teams and manage deliverables in validated environments
- Ensure compliance with GxP regulations and validation processes
- Prepare and review test documentation including plans, protocols, and reports
- Support audits and stakeholder management in regulated settings
Benefits
- general: Range of career paths and internal opportunities within Capgemini group
- general: Personalized career guidance from leaders
- general: Comprehensive wellness benefits including health checks, telemedicine, and insurance with top-ups
- general: Elder care, partner coverage, and new parent support via flexible work
- general: Opportunities to work on cutting-edge projects in tech and engineering with industry leaders
- general: Solutions to overcome societal and environmental challenges
Tags & Categories
Answer 10 quick questions to check your fit for Gxp Functional Test Lead @ Capgemini.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs